Global Regulatory & Scientific Documentation Lead

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 206,000 - 249,000; Full time

Benefits offered by this job

Hybrid work model

Stock options

Job summary

Bristol Myers Squibb in Warsaw, Poland, is seeking a Regulatory Documentation professional to coordinate and author regulatory documents, ensuring cross-functional input and timely delivery. The role emphasizes strong writing and data interpretation skills within a global drug development context.

The position follows a hybrid model with 50% onsite attendance at the Warsaw facility. Competitive compensation is provided with potential incentives and stock opportunities for eligible employees.

Qualifications

• Demonstrated strong writing skills in authoring and managing IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.

Responsibilities

• Coordinate and author regulatory documents (IBs, CSR, protocols) ensuring scientific, medical, and regulatory input is integrated.
• Use document development tools incorporating AI and structured content to enhance efficiency and quality.
• Participate in document strategy sessions and maintain document prototypes and shells.
• Comply with processes and guidelines while managing review timelines and resolving issues with team members.
• Review and edit documents as required.

Skills

Strong writing skills

Cross-functional collaboration

Timeline management

Communication skills

Education

PharmD/PhD in a relevant scientific discipline

Master's/Bachelor's degree

Tools

Document management system

AI document tools

Job description

Bristol Myers Squibb in Warsaw, Poland, is seeking a Regulatory Documentation professional to coordinate and author regulatory documents, ensuring cross-functional input and timely delivery. The role emphasizes strong writing and data interpretation skills within a global drug development context.

The position follows a hybrid model with 50% onsite attendance at the Warsaw facility. Competitive compensation is provided with potential incentives and stock opportunities for eligible employees.